Clinical trial NCT03432416 - References

Female Contraception — Study of Efficacy, Cycle Control, and Safety of a NES-E2 Contraceptive Vaginal Ring

Citation(s)

•   Archer DF, Jensen JT, Johnson JV, Borisute H, Grubb GS, Constantine GD
  Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase 3 study results. Contraception. 2006 Dec;74(6):439-45. Epub 2006 Sep 18.
•   Belsey EM, Machin D, d'Arcangues C
  The analysis of vaginal bleeding patterns induced by fertility regulating methods. World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction. Contraception. 1986 Sep;34(3):253-60.
•   Borch KH, Braekkan SK, Mathiesen EB, Njølstad I, Wilsgaard T, Størmer J, Hansen JB
  Anthropometric measures of obesity and risk of venous thromboembolism: the Tromso study. Arterioscler Thromb Vasc Biol. 2010 Jan;30(1):121-7. doi: 10.1161/ATVBAHA.109.188920. Epub 2009 Oct 15.
•   Brache V, Mishell DR, Lahteenmaki P, Alvarez F, Elomaa K, Jackanicz T, Faundes A
  Ovarian function during use of vaginal rings delivering three different doses of Nestorone. Contraception. 2001 May;63(5):257-61.
•   Daulaire N, Leidl P, Mackin L et al
  , Promises to Keep: The Toll of Unintended Pregnancies on Women's Lives in the Developing World. Washington, DC: Global Health Council; 2002; 11.
•   Finer LB, Henshaw SK
  Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health. 2006 Jun;38(2):90-6.
•   Fraser IS, Weisberg E, Brache V, Alvarez F, Massai R, Mishell DR Jr, Apter D, Gale J, Tsong YY, Sivin I
  Serum Nestorone and ethinyl estradiol levels, and ovulation inhibition in women using three different dosage combinations of a Nestorone progestogen-ethinyl estradiol contraceptive vaginal ring on a bleeding-signaled regimen. Contraception. 2005 Jul;72(1):40-5.
•   Goebelsmann U, Mashchak CA, Mishell DR Jr
  Comparison of hepatic impact of oral and vaginal administration of ethinyl estradiol. Am J Obstet Gynecol. 1985 Apr 1;151(7):868-77.
•   Haukkamaa M, Laurikka-Routti M, Heikinheimo O, Moo-Young A
  Contraception with subdermal implants releasing the progestin ST-1435: a dose-finding study. Contraception. 1992 Jan;45(1):49-55.
•   Heikinheimo O, Noe G, Haukkamaa M, Lähteenmäki P
  The progestin ST 1435--rapid metabolism in man. Contraception. 1994 Sep;50(3):275-89.
•   Heikinheimo O, Ranta S, Moo-Young A, Lähteenmäki P, Gordon K
  Parenteral administration of progestin Nestorone to lactating cynomolgus monkeys: an ideal hormonal contraceptive at lactation? Hum Reprod. 1999 Aug;14(8):1993-7.
•   Isidori AM, Pozza C, Esposito K, Giugliano D, Morano S, Vignozzi L, Corona G, Lenzi A, Jannini EA
  Development and validation of a 6-item version of the female sexual function index (FSFI) as a diagnostic tool for female sexual dysfunction. J Sex Med. 2010 Mar;7(3):1139-46. doi: 10.1111/j.1743-6109.2009.01635.x. Epub 2009 Dec 1.
•   Jensen JT, Burke AE, Barnhart KT, Tillotson C, Messerle-Forbes M, Peters D
  Effects of switching from oral to transdermal or transvaginal contraception on markers of thrombosis. Contraception. 2008 Dec;78(6):451-8. doi: 10.1016/j.contraception.2008.07.004. Epub 2008 Aug 28.
•   Kluft C, Meijer P, LaGuardia KD, Fisher AC
  Comparison of a transdermal contraceptive patch vs. oral contraceptives on hemostasis variables. Contraception. 2008 Feb;77(2):77-83. doi: 10.1016/j.contraception.2007.10.004. Epub 2008 Jan 11.
•   Kumar N, Fagart J, Liere P, Mitchell SJ, Knibb AR, Petit-Topin I, Rame M, El-Etr M, Schumacher M, Lambert JJ, Rafestin-Oblin ME, Sitruk-Ware R
  Nestorone® as a Novel Progestin for Nonoral Contraception: Structure-Activity Relationships and Brain Metabolism Studies. Endocrinology. 2017 Jan 1;158(1):170-182. doi: 10.1210/en.2016-1426.
•   Kumar N, Koide SS, Tsong Y, Sundaram K
  Nestorone: a progestin with a unique pharmacological profile. Steroids. 2000 Oct-Nov;65(10-11):629-36.
•   Marty JP, James M, Hajo N, Wepierre J Percutaneous absorption of oestradiol and progesterone: Pharmacokinetic studies
  In P Mauvais-Jarvis, CFH Vickers, J Wepierre (Eds), Percutaneous absorption of steroids. London: Academic Press Inc. (London) Ltd. 1980.
•   Mashchak CA, Lobo RA, Dozono-Takano R, Eggena P, Nakamura RM, Brenner PF, Mishell DR Jr
  Comparison of pharmacodynamic properties of various estrogen formulations. Am J Obstet Gynecol. 1982 Nov 1;144(5):511-8.
•   Merkatz RB, Plagianos M, Hoskin E, Cooney M, Hewett PC, Mensch BS
  Acceptability of the Nestorone®/ethinyl estradiol contraceptive vaginal ring: development of a model; implications for introduction. Contraception. 2014 Nov;90(5):514-21. doi: 10.1016/j.contraception.2014.05.015. Epub 2014 Jun 2.
•   Odlind V, Lithell H, Selinus I, Vessby B
  Unaltered lipoprotein and carbohydrate metabolism during treatment with contraceptive subdermal implants containing ST-1435. Ups J Med Sci. 1984;89(2):151-8.
•   Pomp ER, le Cessie S, Rosendaal FR, Doggen CJ
  Risk of venous thrombosis: obesity and its joint effect with oral contraceptive use and prothrombotic mutations. Br J Haematol. 2007 Oct;139(2):289-96.
•   Protocol 330
  Clinical Study Report on File. Population Council, New York, NY.
•   Rad M, Kluft C, Ménard J, Burggraaf J, de Kam ML, Meijer P, Sivin I, Sitruk-Ware RL
  Comparative effects of a contraceptive vaginal ring delivering a nonandrogenic progestin and continuous ethinyl estradiol and a combined oral contraceptive containing levonorgestrel on hemostasis variables. Am J Obstet Gynecol. 2006 Jul;195(1):72-7. Epub 2006 Mar 20.
•   Scarabin PY, Oger E, Plu-Bureau G; EStrogen and THromboEmbolism Risk Study Group
  Differential association of oral and transdermal oestrogen-replacement therapy with venous thromboembolism risk. Lancet. 2003 Aug 9;362(9382):428-32.
•   Simmons KB, Kumar N, Plagianos M, Roberts K, Hoskin E, Han L, Alami M, Creasy G, Variano B, Merkatz R
  Effects of concurrent vaginal miconazole treatment on the absorption and exposure of Nestorone® (segesterone acetate) and ethinyl estradiol delivered from a contraceptive vaginal ring: a randomized, crossover drug-drug interaction study. Contraception. 2018 Mar;97(3):270-276. doi: 10.1016/j.contraception.2017.10.010. Epub 2017 Oct 31.
•   Sitruk-Ware R, Plu-Bureau G, Menard J, Conard J, Kumar S, Thalabard JC, Tokay B, Bouchard P
  Effects of oral and transvaginal ethinyl estradiol on hemostatic factors and hepatic proteins in a randomized, crossover study. J Clin Endocrinol Metab. 2007 Jun;92(6):2074-9. Epub 2007 Mar 20.
•   Sitruk-Ware R
  New progestagens for contraceptive use. Hum Reprod Update. 2006 Mar-Apr;12(2):169-78. Epub 2005 Nov 16. Review.
•   Sitruk-Ware R
  Pharmacological profile of progestins. Maturitas. 2008 Sep-Oct;61(1-2):151-7.
•   Sivin I, Mishell DR Jr, Alvarez F, Brache V, Elomaa K, Lähteenmäki P, Massai R, Miranda P, Croxatto H, Dean C, Small M, Nash H, Jackanicz TM
  Contraceptive vaginal rings releasing Nestorone and ethinylestradiol: a 1-year dose-finding trial. Contraception. 2005 Feb;71(2):122-9.
•   Speidel JJ, Harper CC, Shields WC
  The potential of long-acting reversible contraception to decrease unintended pregnancy. Contraception. 2008 Sep;78(3):197-200. doi: 10.1016/j.contraception.2008.06.001. Epub 2008 Jul 9.
•   Timmer CJ, Mulders TM
  Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring. Clin Pharmacokinet. 2000 Sep;39(3):233-42.
•   Weisberg E, Brache V, Alvarez F, Massai R, Mishell DR Jr, Apter D, Gale J, Sivin I, Tsong YY, Fraser IS
  Clinical performance and menstrual bleeding patterns with three dosage combinations of a Nestorone progestogen/ethinyl estradiol contraceptive vaginal ring used on a bleeding-signaled regimen. Contraception. 2005 Jul;72(1):46-52.

A Multicenter, Open-label Randomized Study on the Efficacy, Cycle Control and Safety of a Contraceptive Vaginal Ring Delivering a Daily Dose of Nestorone® and Estradiol (NES-E2 CVR).

Details for clinical trial NCT03432416